Indications and uses
temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes
HISTEX PD Drops New Formulation
- Manufacturer
- Allegis Pharmaceuticals, LLC
- Effective date
- 2025-01-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:51:19
Label at a glance#
ProductHISTEX PD Drops New Formulation
Active ingredientTRIPROLIDINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
Do not exceed recommended dosage. use only the enclosed dropper. do not use enclosed dropper for any other drug products. AGE DOSE Adutls & Children 12 years of age or older: 2 mL (2.5 mg) every 4 to 6 hours, not to exceed 8 mL (10 mg) in 24 hours or as directed by a doctor. Children 6 to under12 years of age: 1 mL (1.25 mg) every 4 to 6 hours, not to exceed 4 mL (5 mg) in 24 hours or as directed by a doctor. Chil...
Storage and handling
Store at 15°-30° C (59°-86° F). Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each 1 mL dropperful)
Triprolidine HCl 1.25 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
Warnings
OTC - DO NOT USE SECTION
Do not exceed recommended dosage.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if the child has
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor before use if the child is taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
- excitability may occur, especially in children
- may cause drowsiness
- sedatives and tranquilizers may increase the drowsiness effect
OTC - STOP USE SECTION
Stop use and ask a doctor if
- new symptoms occur
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Do not exceed recommended dosage.
- use only the enclosed dropper.
- do not use enclosed dropper for any other drug products.
| AGE | DOSE |
|---|---|
| Adutls & Children 12 years of age or older: | 2 mL (2.5 mg) every 4 to 6 hours, not to exceed 8 mL (10 mg) in 24 hours or as directed by a doctor. |
| Children 6 to under12 years of age: | 1 mL (1.25 mg) every 4 to 6 hours, not to exceed 4 mL (5 mg) in 24 hours or as directed by a doctor. |
| Children under 6 years of age: | Consult a docotor. |
Other Information
Store at 15°-30° C (59°-86° F).
Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken.
Inactive ingredients
bubble gum flavor, citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.
Questions? Comments?
Call 1-866-633-9033.
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
NDC 28595-809-30
HISTEX™ PD New Formulation
Drops
Antihistamine
Each dropperful (1 mL)
contains:
Triprolidine HCl
1.25 mg
Sugar-Free • Dye Free
Alcohol Free
Bubble Gum Flavor
1 fl oz (30 mL) Bottle
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 28595-809-30 | HISTEX PD Drops New Formulation | 1 in 1 CARTON | SYRUP | 1 | 3 | |
| 28595-809-30 | HISTEX PD Drops New Formulation | 30 mL in 1 BOTTLE | SYRUP | 30 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 28595-809-30 | ML - Milliliter | 28595-809 | 4ab7a19c-b935-4c90-a32a-c4f05061c7f5 | 1 | 2024-02-14 |
Products#
Every source-derived product name is available through these pages.
- HISTEX PD Drops New Formulation
- TRIPROLIDINE HYDROCHLORIDE
- SUCRALOSE
- SODIUM BENZOATE
- CITRIC ACID MONOHYDRATE
- GLYCERIN
- PROPYLENE GLYCOL
- WATER
- SODIUM CITRATE, UNSPECIFIED FORM
- SORBITOL
- TRIPROLIDINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 28595-809 | 28595-809-30 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | IACT |
| SORBITOL | 506T60A25R | IACT |
| TRIPROLIDINE HYDROCHLORIDE | YAN7R5L890 | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| HISTEX PD Drops New Formulation | TRIPROLIDINE HYDROCHLORIDE | Allegis Pharmaceuticals, LLC | 0c693f15-5d76-3dbf-e063-6294a90af9ac | 2025-01-08 | Warnings | 28595-809-30 28595-809 28595080930 2b39e554-da95-1979-e063-6394a90a887a 0c693f15-5d76-3dbf-e063-6294a90af9ac |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.